FDA Approves New Taxotere Indication as First-Line Therapy for NSCLC

FDA Approves New Taxotere Indication as First-Line Therapy for NSCLC

BRIDGEWATER, New
Jersey-The US Food and Drug Administration
(FDA) has approved
Taxotere (docetaxel, Aventis) as firstline
therapy, in combination with cisplatin (Platinol), in patients with
unre- sectable, locally advanced or
metastatic non-small-cell lung cancer
(NSCLC).
Taxotere is the only agent indicated
both for patients with newly diagnosed
NSCLC, in combination with
cisplatin, and for those with previously
treated advanced NSCLC, as a single
agent, Aventis said in a news release
announcing the approval.
The FDA approval was based on a
randomized controlled international
phase III trial of 1,218 goodperformance-
status patients with
previously untreated advanced
NSCLC. Patients were randomized to
receive Taxotere/cisplatin, Taxotere/
carboplatin (Paraplatin), or a standard
regimen of vinorelbine (Navelbine)/
cisplatin.
Patients in the Taxotere/cisplatin
arm had a median survival of 10.9
months vs 10 months for vinorelbine/cisplatin (P = .035). The overall response
rates were 31.6% for Taxotere/
cisplatin vs 24.4% for vinorelbine/
cisplatin. The Taxotere/carboplatin
combination produced survival and
response rates similar to those seen
with vinorelbine/cisplatin.
Additional study analysis showed
that the benefits from Taxotere/
cisplatin were maintained in patients
who were 65 years of age and older.
This age group accounts for 68% of all
lung cancer patients, according to data
from the National Cancer Institute.
Taxotere/cisplatin also showed clinical
benefits in maintaining body
weight, performance status, and pain
management, compared with
vinorelbine/cisplatin.

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